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"uuid": "ede2ad54-b617-41b5-8e93-35f88283b45b",
"title": "Annexon Reports First Quarter 2024 Financial Results and Key Anticipated Milestones",
"description": "Multiple Value-creating Catalysts Across the Annexon Portfolio Throughout 2024 Pivotal Phase 3 Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected...",
"keywords": "Nasdaq:ANNX, Annexon Biosciences",
"snippet": "Multiple Value-creating Catalysts Across the Annexon Portfolio Throughout 2024\n\nPivotal Phase 3 Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected in Se...",
"url": "https://www.globenewswire.com/news-release/2024/05/13/2880367/0/en/Annexon-Reports-First-Quarter-2024-Financial-Results-and-Key-Anticipated-Milestones.html",
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"published_at": "2024-05-13T12:00:00.000000Z",
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"highlight": "Multiple Value-creating Catalysts Across the Annexon Portfolio Throughout 2024\n\nPivotal Phase 3 Data for ANX005 in Guillain-Barré Syndrome (<em>GBS</em>) Expected in Second Quarter 2024; Potential to be the First Targeted Treatment for <em>GBS</em>\n\nNew Phase 2 Data Showing Neuroprotection of Vision and Vision-Associated Structures by ANX007 in Geographic Atrophy (GA",
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"highlight": "“We are pleased with the increasingly robust opportunities across our flagship programs to drive significant value, including the late-stage potential of ANX005 to be the first targeted treatment for <em>GBS</em> with upcoming pivotal Phase 3 data, the potential of ANX007 to change the GA treatment landscape following first-in-class vision and anatomical neuroprotection",
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"highlight": "Recent Clinical Program Updates\n\nFlagship Programs\n\nANX005 in <em>GBS</em>: First-in-class monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain.",
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"highlight": "Hosted an R&D Day on <em>GBS</em> that covered its serious unmet need, Annexon’s novel targeted approach and the significant market opportunity for <em>GBS</em> in March 2024.\n\non <em>GBS</em> that covered its serious unmet need, Annexon’s novel targeted approach and the significant market opportunity for <em>GBS</em> in March 2024.",
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"highlight": "Ongoing randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial (N=241) designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ANX005 in patients with <em>GBS</em>.",
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"highlight": "Initiated a real-world evidence (RWE) comparability study with global experts in <em>GBS</em> using the International Guillain-Barré Syndrome Outcomes Study (IGOS), with initial RWE data expected by first half of 2025 to support a planned Biologics License Application (BLA) submission.",
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"highlight": "Key 2024 Anticipated Milestones for Flagship Programs\n\nANX005 in <em>GBS</em>: Topline data from the pivotal, randomized, placebo-controlled Phase 3 trial expected in the second quarter of 2024. Initial data from RWE comparability protocol with IGOS expected in first half 2025 to support a planned BLA submission.",
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"highlight": "Research and development (R&D) expenses: R&D expenses were $21.0 million for the quarter ended March 31, 2024, reflecting the advancement of the Company’s priority programs, including <em>GBS</em>, GA and ANX1502, compared to $32.3 million for the quarter ended March 31, 2023.",
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"highlight": "R&D expenses were $21.0 million for the quarter ended March 31, 2024, reflecting the advancement of the Company’s priority programs, including <em>GBS</em>, GA and ANX1502, compared to $32.3 million for the quarter ended March 31, 2023.",
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"highlight": "These forward-looking statements include, but are not limited to, statements about: the timing of completion of Phase 3 trial of ANX005 in patients with <em>GBS</em>; the potential therapeutic benefit of ANX005, if approved, compared to existing therapies; anticipated timing of the completion of a RWE comparability study and BLA submission for ANX005; the potential",
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